Sprout Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for flibanserin, a multifunctional serotonin agonist antagonist (MSAA), for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

The FDA had issued a Complete Response Letter (CRL) for flibanserin in 2013. In response to the CRL, Sprout conducted a Phase 1 pharmacokinetic study and a Phase 1 driving study, which was included in the NDA resubmission.

Previously, flibanserin was evaluated in three pivotal Phase 3, randomized, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years. In all trials, flibanserin demonstrated a statistically significant difference compared to placebo on three key endpoints: an increase of sexual desire; a decrease in distress from the loss of sexual desire; and an increase in the frequency of satisfying sex.

Flibanserin is an investigational, once-daily, non-hormonal drug and if approved would be the first and only post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist available for the treatment of premenopausal women with HSDD. Flibanserin may work by restoring prefrontal cortex control over the brain's motivation/rewards structures enabling sexual desire to manifest. Specifically, flibanserin increases dopamine and norepinephrine while transiently decreasing serotonin in the brain's prefrontal cortex, which may be accomplished by reduced glutamate transmission.